Sleep Apnea, ObstructiveNCT02800798
Correlation Between Preeclampsia and Positive for Obstructive Sleep Apnea Screening Test: STOPBANG Questionnaire
An observational study of Sleep Apnea, Obstructive, run by Ramathibodi Hospital.
Trial summary
The purpose of this study is to find the correlation between high risk OSA (obstructive sleep apnea) patient, based on Stop-bang screening tool and preeclampsia Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Preeclampsia positive
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Thai pregnant women who were scheduled for cesarean delivery or vaginal delivery at Ramathibodi hospital
Who may be able to join
- Pregnant women who were scheduled for cesarean delivery or admitted to the antepartum unit at Ramathibodi hospital
Who cannot join
- Age < 18 year old
- Previous diagnose OSA
- Patients who have used continuous positive airway pressure (CPAP) or bi-level positive airway pressure (Bi-PAP) fro OSA treatment
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to find the correlation between high risk OSA (obstructive sleep apnea) patient, based on Stop-bang screening tool and preeclampsia
Read the detailed description
Obstructive sleep apnea (OSA) has been associated with preeclampsia and intrauterine growth retardation (IUGR).
Since the gold standard diagnosis of OSA is polysomnogram which is limited by cost and availability. Therefore, various screening tools were proposed in order to identify high risk OSA patient such as Stop-bang questionnaire.
From the previous study, Stop-bang showed a high predictive performance and the score equal or higher than 3 determines high risk for OSA.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Preeclampsia positive
- Keywords
- Obstructive sleep apnea, Preeclampsia, Pregnancy, Stopbang
- Medical subject headings
- Sleep Apnea, Obstructive, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preeclampsia positiveOther
Also called Preeclampsia negative
| Study group | Role | What they receive |
|---|---|---|
| High risk for OSA | High risk OSA defines as Stop-bang score ≥ 3 Receives: Other: Preeclampsia positive | |
| Low risk for OSA | Low risk OSA defines as Stop-bang score < 3 Receives: Other: Preeclampsia positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test
Measured: 1 day
Secondary outcomes (5)
prevalence of pre-eclampsia between high and low risk of OSA patient, based on Epworth sleepiness scale
Measured: 1 day
prevalence of pre-eclampsia between high and low risk of OSA patient, based on Berlin questionnaire
Measured: 1 day
prevalence of pre-eclampsia between high and low risk of OSA patient, based on American society check list
Measured: 1 day
The prevalence of maternal adverse event between high risk and low risk of OSA patient
Maternal adverse events include hypoxemia, arrythmia, perioperative myocardial infarction, heart failure
Measured: 1 day
The prevalence of neonatal adverse event between high risk and low risk of OSA patient
Neonatal adverse events include IUGR, neonatal intensive care unit admission, low apgar score
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Sangkum, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800798
- Sponsor's protocol ID
- Ramathibodi
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
PubMed 18431116Pengo MF, Rossi GP, Steier J. Obstructive sleep apnea, gestational hypertension and preeclampsia: a review of the literature. Curr Opin Pulm Med. 2014 Nov;20(6):588-94. doi: 10.1097/MCP.0000000000000097.
PubMed 25250803Antony KM, Agrawal A, Arndt ME, Murphy AM, Alapat PM, Guntupalli KK, Aagaard KM. Association of adverse perinatal outcomes with screening measures of obstructive sleep apnea. J Perinatol. 2014 Jun;34(6):441-8. doi: 10.1038/jp.2014.25. Epub 2014 Mar 6.
PubMed 24603455
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Preeclampsia and Positive for Obstructive Sleep Apnea Screening Test: STOPBANG Questionnaire
- ClinicalTrials.gov ID
- NCT02800798
- Acronym / sponsor ID
- Ramathibodi
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apnea, Preeclampsia, Pregnancy, Stopbang
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find the correlation between high risk OSA (obstructive sleep apnea) patient, based on Stop-bang screening tool and preeclampsia
Detailed description
Obstructive sleep apnea (OSA) has been associated with preeclampsia and intrauterine growth retardation (IUGR).
Since the gold standard diagnosis of OSA is polysomnogram which is limited by cost and availability. Therefore, various screening tools were proposed in order to identify high risk OSA patient such as Stop-bang questionnaire.
From the previous study, Stop-bang showed a high predictive performance and the score equal or higher than 3 determines high risk for OSA.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk for OSA | – | Other: Preeclampsia positiveHigh risk OSA defines as Stop-bang score ≥ 3 |
| Low risk for OSA | – | Other: Preeclampsia positiveLow risk OSA defines as Stop-bang score < 3 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thai pregnant women who were scheduled for cesarean delivery or vaginal delivery at Ramathibodi hospital
Key inclusion criteria (1 listed)
- Pregnant women who were scheduled for cesarean delivery or admitted to the antepartum unit at Ramathibodi hospital
Key exclusion criteria (3 listed)
- Age < 18 year old
- Previous diagnose OSA
- Patients who have used continuous positive airway pressure (CPAP) or bi-level positive airway pressure (Bi-PAP) fro OSA treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preeclampsia positiveAlso: Preeclampsia negative | Other | High risk for OSA, Low risk for OSA |
Primary outcome
Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test
Time frame: 1 day
5 secondary outcomes
prevalence of pre-eclampsia between high and low risk of OSA patient, based on Epworth sleepiness scale
Time frame: 1 day
prevalence of pre-eclampsia between high and low risk of OSA patient, based on Berlin questionnaire
Time frame: 1 day
prevalence of pre-eclampsia between high and low risk of OSA patient, based on American society check list
Time frame: 1 day
The prevalence of maternal adverse event between high risk and low risk of OSA patient
Time frame: 1 day
The prevalence of neonatal adverse event between high risk and low risk of OSA patient
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Background: PubMed 18431116Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
- Background: PubMed 25250803Pengo MF, Rossi GP, Steier J. Obstructive sleep apnea, gestational hypertension and preeclampsia: a review of the literature. Curr Opin Pulm Med. 2014 Nov;20(6):588-94. doi: 10.1097/MCP.0000000000000097.
- Background: PubMed 24603455Antony KM, Agrawal A, Arndt ME, Murphy AM, Alapat PM, Guntupalli KK, Aagaard KM. Association of adverse perinatal outcomes with screening measures of obstructive sleep apnea. J Perinatol. 2014 Jun;34(6):441-8. doi: 10.1038/jp.2014.25. Epub 2014 Mar 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Ramathibodi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Sangkum, MD (6622011513, lisa.sangkum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800798, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.